Clinical Question

Does testosterone therapy increase the risk of myocardial infarction (MI) in men?

Bottom Line

Filling a prescription for testosterone therapy is associated with an increased likelihood of experiencing an MI, especially in older men and those with a history of cardiovascular disease. (Level of Evidence = 2b)

Synopsis

Men are increasingly taking testosterone supplements, even if they are not hypogonadal. In addition to an absence of evidence regarding effectiveness, previous studies have raised concerns about the safety of this practice. These researchers identified a large cohort of men who had received a first prescription for testosterone therapy (N = 55,593) and compared them with men who had received a prescription for a phosphodiesterase type 5 inhibitor (sildenafil [Viagra] or tadalafil [Cialis]; N = 167,279). All had at least 22 months of continuous follow-up; men with a history of MI before the prescription were excluded from analysis of postprescription outcomes. The database does not have information on lifestyle or actual use, only whether prescriptions were filled. The relative risk (RR) of MI was higher during the period after a prescription for testosterone therapy was given than before (RR = 1.36; 95% confidence interval [CI], 1.03 to 1.81). This effect was more pronounced in patients older than 65 years (RR = 2.19; 95% CI, 1.27 to 3.77) than in younger men (RR = 1.17; 95% CI, 0.84 to 1.63), for whom the increase was not statistically significant. A similar increase in risk was not seen after prescription of a phosphodiesterase type 5 inhibitor. There was a trend toward increasing risk with older age, including an RR of 3.4 (95% CI, 1.54 to 7.66) for men 75 years and older. Younger men with a history of heart disease also had an increased risk of MI. Biological plausibility is enhanced by the fact that risk returned to normal after prescriptions were not refilled.

Study design: Cohort (prospective)

Funding source: Government

Setting: Population-based

Reference: FinkleWDGreenlandSRidgewayGKet alIncreased risk of non-fatal myocardial infarction following testosterone therapy prescription in men. PLoS One.2014; 9( 1): e85805.